# FDA recall Z-0141-2018

> **Exactech, Inc.** · Class II · device recall initiated 2017-09-19.

## Product

Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Beta, Ref 208-04-44, Sterile, RX.  .

## Reason for recall

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

## Distribution

Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA,  and Puerto Rico.  Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.

## Key facts

- **Recall number:** Z-0141-2018
- **Recalling firm:** Exactech, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-09-19
- **Report date:** 2017-11-29
- **Termination date:** 2021-06-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Gainesville, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0141-2018

## Citation

> AI Analytics. FDA recall Z-0141-2018. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-0141-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*